The present invention relates to semi and fully-implantable hearing aid systems, and more particularly, to an interconnection apparatus and method that simplifies implant procedures and facilitates selective removal/replacement of one or more of the implanted components of a hearing aid system.
A number of implantable hearing aid devis have been developed for stimulation of the ossicular chain and/or oval window. Such devices can offer superior sound quality and amplification relative to conventional acoustic hearing aids (e.g., devices insertable into the ear canal), while avoiding known shortcomings of acoustic hearing aids (e.g., feed-back emissions, etc.).
Known implantable hearing aid devices include those which utilize implanted electromechanical transducers positioned within the middle ear for stimulation of the ossicular chain and/or oval window (see e.g., U.S. Pat. No. 5,702,342), and those which utilize implanted exciter coils to electromagnetically stimulate magnets affixed in the middle ear(see e.g., U.S. Pat. No. 5,897,486). For purposes hereof, such electromechanical transducer and exciter coil magnet arrangements, as well as other implantable middle ear devices capable of stimulating the ossicular chain and/or oval window, will be collectively referred to as xe2x80x9cimplantable middle ear actuators.xe2x80x9d
In addition to implantable middle ear actuators, other components of implantable hearing aids systems may be located subcutaneously. By way of example, such additional components may include a receiver for receiving RF signals from an external transmitter and processing electronics to process the received signals and provide an appropriate output signal to an implantable middle ear actuator.
In conjunction with implant procedures, the various implanted components of a given system may entail positioning at a number of differing locations proximal to the mastoid process of a given patient. As will be appreciated, such positioning may require a number of different surgical steps, including for example, the placement of an implantable middle ear actuator through a hole drilled into the mastoid process. Given such positioning requirements, initial component placement can be a challenging procedure and removal/repositioning of selected implanted components of a given implantable hearing aid system (e.g., for reprogramming, replacement, servicing, etc.) may be problematic after the initial implant procedure.
In view of the foregoing, a primary objective of the present invention is to provide an implantable hearing aid apparatus and method that facilitates the initial positioning of multiple implanted components comprising a given hearing aid system.
An additional objective of the present invention is to provide an implantable hearing aid apparatus and method that facilitates selective replacement/servicing/repositioning of implantable components comprising a given implantable hearing aid system.
Yet a further objective of the present invention is to provide an improved implantable hearing aid apparatus and method that satisfies one or both of the above-noted objectives, while also maintaining the integrity of the operative interconnections made between the different implantable components.
The above-noted objectives and additional advantages may be realized in an inventive apparatus which includes an implantable male connector and an implantable female connector for selectively and slidably receiving the male connector in a recess of the female connector. More particularly, the implantable male and female connectors may each comprise outer housings which may be matably and sealably interconnected, and at least one internal conductor, wherein the respective conductors are selectively interconnected upon adjoinment of the respective outer housings for subcutaneous signal transmission. In this regard, the internal conductor(s) of the male connector and the internal conductor(s) of the female connector may be operably interconnected for signal transmission with separate and different implantable components included in a given implantable hearing aid system. By way of example, such implantable components may be of a type included within an implantable hearing aid component group consisting of: an implantable middle ear actuator, an implantable signal processor, an implantable transcutaneous signal receiver, an implantable microphone and an implantable power source.
In one particular aspect of the invention, at least one pair of the implantable male connector and a first component of the implantable hearing aid component group, and the female connector and a second component of the implantable hearing aid component group, may be non-releaseably interconnected. By way of primary example, said at least one pair may be sealably disposed within a common support structure that serves to define the outer housing of the male or female connector included in the pair. Further in this regard, the support structure may be integrally defined (e.g., via a molding process) and may comprise a biocompatible material selected from a group consisting of:
an elastomeric material (e.g., silicon-based);
an epoxy-resin material; and
a ceramic material.
Such materials may be molded about a male or female connector, and one or more implantable hearing aid components, so as to support and insulate such items, while also sealably encapsulating the implantable hearing aid components.
Preferably, the support structure is of a wafer configuration having a predetermined maximum thickness of about 8 mm, and most preferably a predetermined maximum thickness of about 6 mm. Such configuration facilitates subcutaneous placement of the support structure exterior to the skull of a patient, and also serves to minimize any observable protrusion. Further in this regard, it is preferable for the male and female connectors to be oriented for selective interconnection through a side of the wafer-configured support structure (e.g., as opposed to being interconnected through a top or bottom surface of the support structure).
In another specific aspect of the invention, the inventive apparatus may further comprise at least one locking member positionable through the outer housing of the female connector to selectively lock the male connector and female connector in an interconnected relationship. Preferably, when a common support structure is utilized the locking member(s) is disposed for positioning through the side of the support structure (e.g., as opposed to a top or bottom surface of the support structure), so as to contribute to a reduced thickness profile. In this regard, the locking member(s) may be preferably insertable into an opening(s) in the support structure that transversely adjoins the recess of the female connector, wherein the internal conductor(s) of the female connector is also partially disposed within such opening(s).
In an additional aspect of the present invention, the internal conductor(s) of both the female connector and male connector, as well as the locked member(s) if included, may comprise substantially the same conductive metal so as to substantially reduce or avoid any galvanic potential. By way of example, such conductive metal may comprise a metal selected from a group consisting of: titanium, gold, and platinum. Further in this regard, one or more of the components comprising the implantable hearing aid component group optionally employable with the present invention may advantageously comprise or be disposed within a housing comprising a metal selected from the above-noted group.
In yet an additional aspect, the male connector of the inventive apparatus may comprise a central conductor and an outer conductor (e.g., separated by an insulating member therebetween). Further, the female connector may include a conductive first contact member and a conductive second contact member having openings therethrough for slidably receiving the central conductor and outer conductor of the male connector, respectively. To facilitate slidable interconnection between the male connector and female connector, the central conductor and outer conductor of the male connector, as well as the openings in the first and second contact members of the female conductor may be coaxially disposed. In such an arrangement, two locking members may be employed, wherein a first locking member may be disposed through a side opening in the female connector (e.g. aligned side openings through a support structure and the first contact member) to secureably engage the central conductor, and wherein a second locking member may be disposed through a side opening in the female connector (e.g., aligned side openings through a support structure and the second contact member) to secureably engage the outer conductor. In this regard, the first and second locking members may be externally threaded set screws for selective threaded engagement with internally threaded surfaces provided in corresponding side openings of the first and second contact members. First and second separate seal cap members may be provided for insertion into and snap-in engagement with the female connector, thereby sealing the various locking interconnections. The seal cap members may comprise a resilient material and include a central slit that facilitates tool insertion/access therethrough to set screws for selectively xe2x80x9cunlockingxe2x80x9d of the male connector/female connector (e.g., for component replacement/servicing purposes).
In one embodiment of the present invention an implantable hearing aid apparatus includes an implantable first connector having an outer housing and at least one internal conductor, said at least one internal conductor being operatively interconnected for signal transmission with a middle ear actuator. The apparatus further includes an implantable second connector for selectively and sealably receiving the first connector and having an outer housing and at least one internal conductor. The internal conductor of the second connector is operatively interconnected for signal transmission with an implantable signal processor. Upon selective interconnection of the first connector and second connector, the implantable middle ear actuator and implantable signal processor are operable for subcutaneous signal transmission therebetween.
In the above-described embodiment, the second connector and signal processor may be non-releasably interconnected within a common support structure. Such common support structure may be integrally defined by a molded material, wherein the common support structure has a predetermined maximum thickness of less than about 8 mm for profile reduction purposes. Further, the first connector and second connector may be selectively interconnectable within the support structure through a side surface thereof.
In conjunction with the present invention, an inventive method for use of implantable hearing aid system is also provided. In particular, the inventive method may comprise positioning a first component of an implantable hearing aid system at a first subcutaneous location relative to a patient""s skull, wherein the first component is interconnected to a first connector, and the first component is one of an implantable hearing aid component group consisting of: an implantable middle ear actuator; an implantable signal processor; an implantable transcutaneous signal receiver; an implantable microphone; and an implantable power source. The method may further include the step of locating a second component of an implantable hearing aid system at a second subcutaneous location relative to the patient""s skull, wherein the second component is interconnected to a second connector that is one of said implantable hearing aid device group. As will be appreciated, the inventive method may also include the step of selectively interconnecting the first and second connectors to establish a sealed, electrical interconnection between corresponding internal conductors disposed within the first and second connectors so as to provide for operative signal transmissions between said first and second implantable components. Of note, to facilitate positioning of the first and second components, the selective interconnection step may preferably be completed after the positioning and/or locating steps (i.e., with the first and/or second components already located in-situ).
The method may further include the step of selectively advancing at least a first locking member through the outer housing of the female connector to secureably interconnect the internal conductors of the first and second connectors. In particular, the first locking member and internal conductor of the female connector may be provided for threading engagement therebetween, wherein the locking member may be rotated into locking engagement with the internal conductor of the male connector.
In a particular application of the method, the first component may comprise an implantable middle ear actuator, wherein the method further includes the step of positioning the implantable middle ear actuator through an opening defined in the mastoid process of a patient""s skull. In this regard, such positioning step may provide for contact between a probe end of the middle ear actuator and a middle ear bone or oval window of a patient.
In conjunction with the inventive method, it should be appreciated that the first connector and second connector may be selectively disconnectable, thereby facilitating removal/repositioning of the second component from its corresponding second subcutaneous location while maintaining the first component (e.g., middle ear actuator) at its first subcutaneous location. Such disconnection capability facilitates post implant procedures, including for example reprogramming of an implantable signal processor, servicing of implantable components, etc.
Numerous additional features and advantages of the present invention will become apparent to those skilled in the art upon consideration of the further description that follows.